Local Application of Vancomycin Powder in Grade I-IIIA Open Fractures
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- University of Tennessee
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Postoperative Infection
Study Overview
Brief Summary
The purpose of this study is to determine if local administration of vancomycin powder at the site of Grade I-IIIA open fractures at the time of surgery will be an efficacious method to lower infection rates in open fracture treatment and to elucidate any detrimental effects of applying vancomycin powder at the site of open fractures.
Detailed Description
Hypothesis
Local administration of 1 gram of vancomycin powder at the site of primarily closeable Gustilo-Anderson Grade I-IIIA open fractures at the time of surgery, in addition to clinically accepted open fracture management (intravenous antibiotics, surgical irrigation and debridement and stabilization), will significantly decrease the postoperative infection rate in comparison to the current treatment algorithm.
Methods:
Study subjects will be randomized to one of two groups prior to surgery (parallel group design): standard treatment (control group) versus vancomycin powder treatment (experimental group). Each group will have an equal number of subjects. Once randomized, the intervention is then un-blinded to facilitate treatment.
Post-operatively, all patients will receive intravenous antibiotics, such that all patients receive a total of 24 hours of intravenous antibiotics. The surgical drain will be removed at the patient's bedside approximately 24 hours after the surgical procedure. Patients will follow up with their surgeon for routine scheduled visits at approximately 2 weeks, 6 weeks, 12 weeks, and further until aseptic union or resolution of infection. There will be no additional appointments solely for the purpose of research follow-up.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Skeletally mature patients ≥18 years of age
- •Acute Gustilo-Anderson Type I-IIIA open fracture
- •Fracture is deemed primarily closable at initial surgery
- •Likely to follow-up with surgeon until fracture is healed
- •Ability to understand and agree to Informed Consent
Exclusion Criteria
- •Patients <18 years of age
- •Gustilo-Anderson Type IIIB and IIIC open fractures
- •Open fractures requiring multiple operations (i.e. for repeat surgical debridement or staged bone grafting of critical segmental defects)
- •Delayed presentation of open fracture
- •Pre-existing systemic infection requiring antibiotic therapy
- •Allergy to Vancomycin
- •Open fracture at the site of a previous fracture or surgical site
- •Current skin infection, chronic wounds or known systemic infection
- •Unlikely to follow-up until fracture is healed
- •Unable to understand or agree to Informed Consent
Arms & Interventions
Vancomycin Powder
If the patient randomizes to the experimental group (vancomycin powder), the patient will receive open fracture care identical to the control group except that, prior to closure, 1 gram of vancomycin powder will be applied locally to the open fracture bed. The traumatic and surgical wounds will be closed over a sterile drain and dressed, and the extremity will be immobilized.
Intervention: Vancomycin (Drug)
Outcomes
Primary Outcomes
Postoperative Infection
Time Frame: one year
Infections will be considered clinically significant if they require a return to the operating suite for surgical debridement. These infections will be classified as acute infections and/or chronic osteomyelitis. Superficial skin infections will be treated with local wound care, oral antibiotics and incision and drainage (as indicated). Deep infections and chronic osteomyelitis will be treated with staged serial surgical debridement, hardware removal (as indicated), culture specific IV antibiotics, and Infectious Disease consultation.
Secondary Outcomes
No secondary outcomes reported